MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFEN XTAB 7X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	186770445
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient had spinal fusion surgery.Immediately after the surgery the patient felt good, but one week after, the patient was at the emergency room with an allergic reaction.He was given benadryl and symptoms improved.His condition has deteriorated and in pain every day.He had a prior surgery in the 1990s where stainless steel or titanium rods and screws were implanted in his hand and had to be removed because of allergic reaction that caused the surgery site not to heal.Upon removal of the implants, the hand healed.The current surgeon was notified of the issue with the prior surgery but insisted that materials had changed since the 1990s and the possibility of an adverse reaction were minuscule.Because of the patient urged the surgeon to get him allergy tested because of how he feels, he did put in an order and was tested, however, upon completion of the testing he was told he was tested for the wrong items.The patient have not heard back from anyone and now taking his healthcare into his own hands and would like to have independent allergy testing performed.The patient needs information from the company in order to do so.This is report 3 of 10 for (b)(4).This (b)(4) capture the 10 out of 12 devices reported/ received and (b)(4) capture the other 2 out of 12 devices reported/ received.

• Brand Name: VIPER PRIME CFXFEN XTAB 7X45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9590957
• Report Number: 1526439-2020-00379
• Device Sequence Number: 13576048
• Product Code: NKB
• UDI-Device Identifier: 10705034509617
• UDI-Public: (01)10705034509617
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 186770445
• Device Catalogue Number: 186770445
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 103